Evaluation of Performance and Safety of INNEA and INNEA AQUA for the Treatment of Cheek and décolletage Wrinkles
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
A Post-Market, Single-arm, Confirmatory Interventional Clinical Investigation to evaluate the Performance and Safety of INNEA and INNEA AQUA for the treatment of cheek and décolletage wrinkles
Eligibility Criteria
Inclusion Criteria: 1. Patient Informed consent form (ICF) signed; 2. Female Subjects between 35 and 65 years old at the time of the signature of ICF; 3. Subjects with at least 2 (shallow wrinkles) on the Lemperle Rating Scale requiring correction of cheek wrinkles and/or subjects requiring correction of décolletage wrinkles; 4. Willingness to follow all study procedures, including attending all site visits, tests and examinations; 5. Agreeing to present at each study visit without make-up; 6. Willingness not to undergo other procedures involving aesthetic correction (e.g., ultrasound-based treatments, biomaterial implant, lifting, botulinum toxin injections, laser or intense pulsed light treatment, bio-stimulating treatment, chemical peeling, dermabrasion, fillers) during the entire study period; 7. Willingness to follow indications to not be exposed to make-up for 12 hours after injection; 8. Willingness to avoid prolonged exposure to sunlight and UV or using saunas or Turkish baths